RIGHTWHEY - Responders In Gut HealTh Markers Using Fermented WHEY

NCT ID: NCT03844152

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-13
• Study Completion Date: 2020-04-08

Brief Summary

This 8-week intervention will investigate the effect of daily consumption of a fermented whey concentrate on the short-chain fatty acid profile of faeces in healthy individuals.

This study will help us understand if consumption of fermented foods rich in lactic acid have a beneficial effect on gut health.

Detailed Description

The 8-week dietary supplementation trial will investigate the action of exogenous lactic acid consumption on the activity (using short-chain fatty acid) and composition of the gut microbiota.

Participants will be stratified according to their baseline faecal butyrate levels. Therefore volunteers will be asked to provide two faecal samples one week apart. Based on the average absolute level of butyrate in the faecal samples, volunteers will be stratified into either low, moderate or high baseline butyrate levels (detailed in table 1 below). The levels for faecal butyrate for each group are set based on a meta-analysis of 9 human studies of healthy volunteers carried out at the Rowett Institute (n=116; LaBouyer et al, 2016, unpublished). Thresholds were derived from the boundaries of tertiles. Therefore, the moderate butyrate producers represent the middle 33% (see table). Each stratification arm will have a minimum of 17 study volunteers bringing the total to n=51. This has been set to ensure the completion of at least 45 volunteers. To optimise equal gender distribution amongst all study arms a minimum of 5 females and 5 males will be recruited for each arm.

Stratification Butyrate range Low ≤13 mM Moderate butyrate 13 - 20mM High butyrate ≥20mM

Primary and secondary outcomes will be analysed between the low and high butyrate producing groups as well as the overall group effect on everyone.

Conditions

Health, Subjective; Healthy; Microbial Colonization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fermented whey concentrate

Volunteers will receive the premixed water and fermented whey in weekly deliveries in 1.5L bottles and a drinking glass with a clear indication of the required 200ml volume. Participants will be asked to drink 200 ml of the supplemented water twice daily for the active intervention period.

Group Type: EXPERIMENTAL

Fermented whey concentrate

Intervention Type: DIETARY_SUPPLEMENT

The investigated dietary supplement is a form of lacto-fermented whey concentrate (FWC), which has been deproteinised and then diluted (1/20) in sugar-free flavoured water to improve palatability. The main solute within the lacto-fermented whey is L-(+)-lactic acid (7%), produced through bacterial fermentation of the milk sugar lactose. The research team will provide non-descriptive bottles of drink to all volunteers. The flavour of the FWC will be masked by the flavoured water. In order to assess compliance and minimize an initial treatment effect, a 14 day run-in period during which only flavoured water is to be consumed will be completed by all volunteers. At the same time, this period will act as a wash-out, as volunteers will be asked to abstain from the use of any dietary supplements during this period and the rest of the study. The daily energy content of the FWC is 4kcal.

Interventions

Fermented whey concentrate

The investigated dietary supplement is a form of lacto-fermented whey concentrate (FWC), which has been deproteinised and then diluted (1/20) in sugar-free flavoured water to improve palatability. The main solute within the lacto-fermented whey is L-(+)-lactic acid (7%), produced through bacterial fermentation of the milk sugar lactose. The research team will provide non-descriptive bottles of drink to all volunteers. The flavour of the FWC will be masked by the flavoured water. In order to assess compliance and minimize an initial treatment effect, a 14 day run-in period during which only flavoured water is to be consumed will be completed by all volunteers. At the same time, this period will act as a wash-out, as volunteers will be asked to abstain from the use of any dietary supplements during this period and the rest of the study. The daily energy content of the FWC is 4kcal.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Molkosan

Eligibility Criteria

Inclusion Criteria

• i. Men and women aged 18-68 years; BMI ranging from 18-35 kg/m2; measured at the screening visit

Exclusion Criteria

• i. smokers
• ii. subjects with: diagnosis of diabetes, pregnant, hypertension, renal, hepatic, haematological disease, coronary heart disease or any gastrointestinal disorder
• ii. unsuitable veins for blood sampling;
• iii. inability to speak, read and understand English.
• iv. Use of antibiotics within the last 3 months will automatically exclude volunteers.
• v. Vegans. Fermented whey concentrate, (FWC), is derived from milk (animal product) which excludes potential participants adhering to a vegan diet.
• vi. allergy to any of the following: cow milk, lactose, casein, whey, sucralose, acesulfame K, citric acid, potassium benzoate, fruit flavourings.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

A. Vogel

UNKNOWN

Sponsor Role: collaborator

University of Aberdeen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra M Johnstone, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Karen P Scott, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

The Rowett Institute, Human Nutrition Unit

Aberdeen, , United Kingdom

Countries

United Kingdom

Other Identifiers

808

Identifier Type: -

Identifier Source: org_study_id